BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISON DENTAL ALLOY

    MDR report key: 35186 · Received August 12, 1996

    Report

    Report Number
    MW1009696
    Event Type
    Malfunction
    Date Received
    August 12, 1996
    Report Date
    July 23, 1996
    Manufacturer
    DENTSPLY INTERNATIONAL, INC.
    Product Code
    EJJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    UPON TRITURATION THERE WERE NUMEROUS CAPSULES THAT CONTAINED EXCESS POWDER AND/OR EXCESS LIQUID AND RESULTED IN MATERIAL NOT SUITABLE FOR RESTORATIVE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISON DENTAL ALLOY DENTAL ALLOY EJJ DENTSPLY INTERNATIONAL, INC. 950311E, 950411E

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO